Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease

• Status: Terminated
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the effect of alkali administration on bicarbonate and potassium levels in patients with Sickle Cell Disease (SCD) and depressed serum bicarbonate levels. The study is a prospective non-blinded evaluation of tolerability and efficacy of alkali repletion with 4 weeks of observation and two sequential 4 week courses of escalating oral sodium bicarbonate treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center

Criteria

Inclusion Criteria:

• Sickle cell disease patients with HbSS

• eGFR <90 ml/min/1.73m2 (determined by abbreviated 4 variable modification MDRD equation) and/or measured urinary albumin to creatinine ratio >30mg/g.

• Age ≥18 years

Exclusion Criteria:

• Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)

• Bicarbonate level >25 mEq/L

• Decompensated heart failure

• Uncontrolled systolic blood pressure >140 mm/Hg (the cutoff for systolic hypertension in SCD is lower than in non-SCD)

• Moderate-to-severe lower extremity edema

• Projected progression to ESRD within 6 months

• Kidney transplantation

• Treatment with immunosuppressives within the last 3 months

• Vasoocclusive (VOC) within 1 week of study entry

• Active (open) leg ulcer

• Change in hydroxyurea dose within the last 3 months, unless a self-limited interruption of a stable dose

• Blood transfusion within 8 weeks, unless on chronic transfusions

• Pregnancy

• Inability to give informed consent